Fabric with active principles and relevant recharging method of the active principles

ABSTRACT

The fabric consists of lycra fibres and microfibres and it has long the fibres a glycoprotein ( 9 ) and an exapeptide ( 10 ). The woof of this fabric and the active principles given to these two substances ( 9, 10 ) prevent and/or give the first cures to the diabetic foot.

FIELD OF THE INVENTION

The present invention refers to a fabric with active principles and to arecharging method of said principles having the main aim to preventand/or to give the first cures to the diabetic foot.

BACKGROUND ART

Between the diabetes complications are known the problems to the feetcaused to ulcers, accidental injuries, micro-traumas, wounds also light,callosity and infections. Are known the grave damages and the risks ofgrafting of important complications from light wounds in the diabeticpatient. The persons with these pathologies have a reduced flux of blondin the inferior arts, in particular from the knee to the foot, owing toa stricture of the arteries. Moreover, the diabetes gives a progressivedestruction of the nerves that arrive to the foot and to a skindegeneration, that becomes dry and inflexible, so easy to be subjectedto wounds. The concomitance of these events determines infections oftencareless and minimal realized to the diabetic patient, this due also toa minor sensibility of the nervous terminations of the foot. Thedegenerative forms created to a light wound are, owing to thecomplications given to the metabolic, circulatory and neurologicalalterations, not to disregard as they easily evolve in seriouspathologies, unfortunately favourite to long times for healing thewounds in the diabetic patient, with consequent increasing of risk ofbacterial, viral and mycotic infections. The complications of a normaldisregarded ulceration are one of the more frequent causes of admissionto hospital for this pathology. The non-prevention and non-care of thatknown as diabetic foot determines the claudication and, in the gravecases, the amputation of the art. A consistent percentage of diabeticpersons are subjected to ulcerations to the feet that prolong in thetime can grow worse. To have an idea of the problem are cited the dataof the Health World Organization where are counted in one hundred andtwenty million the diabetic persons in year 1996 and it is estimated inthree hundred million the number of diabetic persons in year 2025, whereon an average the 15% will have ulcerations to the feet withcomplications. Always from the cited sources are known data that countedthat for one hundred diabetic patients with amputations eighty-four havehad as cause of the amputation an ulceration to a foot grows worse intime. Moreover, over the 50% of all the amputations of the lower limbsregards diabetic patients. Currently are not known local preventiveapplications to be constantly used to prevent, cure or reinforce thedefences of the foot of the diabetic patient so to avoid thecomplications previous described. The sole forms of prevention in thisdelicate sector are given prevalently based onto mode of behaviour asthe careful test of the food, the sanitary education for observation ofhygienic rules, the using of correct shoes and the application oftopical remedy at the appearing of the first ulcerations.

SUMMARY OF THE INVENTION

The invention, instead, realizes a therapeutic remedy able to preventthe formation of ulcerations and to favourite the recovery of woundseventually formed. The invention creates a fabric, for specificapplication in this pathology, impregnated with substances withsynergetic action and gradual release, and a recharging method of saidactive substances when these have lost their efficacy in time. Therecharging of the active principles to the fabric permits a reusing ofthe specific fabric and it permits to have a set of clothes withcontrolled release of the active substances.

DETAILED DESCRIPTION OF THE INVENTION

The invention consists of a fabric 1 in lycra fibres and micro-fibres(known with the trade “meryl”), in variable percentages for applicationof this kind, that in actuation has the form of stocking 2, pantyhose 3,sock 4, winding bandage with closed border 5, bandage or plaster 6. Thistype of fabric, with new application for the specific pathology of thediabetic foot, has the characteristic to have fibres with minor or equalsubtlety to ten micron. So the fibres of this fabric are of inferiordiameter to that of the silk, that have a subtlety of the fibres oftwelve micron, of the cotton with subtlety of the fibres of thirteen andhalf micron, of the cashmere with fibres diameter dimension of fifteenmicron and of the wool with fibres diameter dimension of seventeenmicron. The application of this characteristic of the invention is ofbig importance for the diabetic foot such as more the thread is thinminor are the damages to abrasion of the fabric onto the skin. So anextremely smooth fabric is obtained that no creates micro-abrasions ontothe inelastic skin and dry of the diabetic patient. In other embodimentof the invention the fabric 1 is provided in the woof of thin silveryarns 7 with function anti-bacteric and bacteriostatic. To avoid grazesfrom sewing the invention, in the form of the stocking 2, pantyhose 3,sock 4, has a sewing with flat folding 8 in the anterior part of thestocking, imperceptible to the touch. The fabric 1, moreover, haselastic property (elasticity of 99-100%) so to not obstruct the venousflux, to not worsening the occlusive peripheral arterypatia and tofavourite the local microcirculation. Unlike to the other syntheticfibres, moreover, it has capacity of umidity absorption, low rate ofwater retention and, differently to the natural fibres, quick time ofdrying. These characteristic have like resulting capacity to oppose theformation of fungus and to limit the bacteric growth. To the fabric 1are then added active substances with application method to the fabricand recharging method of new conception. To the fabric 1 is bound aglycoprotein 9 (pseudoalteromonos ferment extract, known with the trade“antarcticine”) synthesized to a bacteria (pseudoalteromanas antarticaNF3) of the species Gram-negative, with composition of the fat acids andto the proteinic outline typical of the alteromonas family. Thissubstance during the cellular growth produces a glycoprotein exopolymercomposed of the 76-86% of proteins and to 8-14% of sugar, in base of theused means. This active substance have had use, previous to theinvention, like a cosmetic humectant and emollient ingredient and like asubstance with crioprotective property. Said active principle, of newand original application in the treatment of the diabetic foot, hasimportant property that opposed the dryness of the skin typical of thediabetic patient. It gives, infact, the coesion between the spinous andgerminativum stratum favouring the madding and the folding of theinterkeratociti liquids, so as estimated through the compression studiesof the isotherms and of the multilayer of the Langmuir balance.Moreover, said substance stimulates the growth of the human skinfibroblast in the tests in vitro without the growth of the keratinociti,so acting onto the micro-ulcerations of the skin to their first turningup and onto all the cute surface, from the knee to the foot. Moreover,the active principle given to the cited substance increases theformation of elastin and of collagen type I and type IV hours incomparison, with a sample of skin not treated or treated with cream withthe only placebo effect. This substance is inserted in the wet fabric ina quantity of at least 1 mg/ml. To the fabric 1 is then added, withoutorder of insertion to the fabric but with modality of charge andrecharge following described, an exapeptide 10 from the alpha chain(known with trade “serilesine”). This peptide increases the adhesion ofthe cells, favours the cellular proliferation and betters themicrocirculation such as it favours the angiogenesis. This activesubstance is added to the wet fabric 1 in quantity at least of 0.05mg/ml. Also this last substance is never previous used for the use inpathology such that of the diabetic foot. Both these substances areprevious used in the cosmetic field. So they do not present toxicityproblems and they are not to be considered drugs to be prescribed withprescription. In particular they do not have, such the made tests hascertified, cytotoxicity on human fibroblasts, cytotoxicity onkeratinocity, they have no given toxicity prove in the tests ofhemolysis, in the tests of genotoxicity, i.e. in the Ames tests, andthey are not irritating as valuing with the het-cam for the valuation ofthe potential ocular irritation. The used substances in the describedconcentrations do not create irritation to the skin, sensitizationphenomenon, ocular irritation and oral and skin toxicity. Thesesubstances 9 and 10 are moreover bound to the fabric 1 essentially forcoulomb bond, being they with prevalent positive charge whereas thefabric has fibres with negative charge for own constitution. Thesubstances 9 and 10 are mixed into microcapsules 11 soluble in water.The fabric 1 is then washed in water at 50° C. Ending this, working thewater is discharged and the fabric is wet with clean water to which isadded a mordanting assistant 12, the nylofixan PM (known with trade“clariant”) that has the function to bound the substances contained inthe microcapsules 11 to the aminic group of the fabric 1, by means ofthe polarization that favours the union between the fabric 1 and thesubstances 9 and 10 into the microcapsules.

The fixer 12 is then added in proportion of 4% of the weight of thefabric 1 to treat. Then are introduced in the bath the microcapsules 11in the dose previous described and in total quantity of the 6% of theweight of the fabric. After ten minutes is added a cationic product 13,i.e. softenol 70 (known with trade “lautex”) that contributes also it tobound the microcapsules 11 with the fabric 1. The “lautex” is added inpercentage of 2% of the weight of the fabric. After ninety minutes thebath is let out and the fabric I is centrifuged and dry, ready to beused. In the version for the domestic use the microcapsules 11 and thefixers 12 and 13 to the fabric 1 are sold in pre-dosed packaging, to canuse the stocking 2, the pantyhose 3, the sock 4, the winding bandage 5,the bandage or plaster 6. To actuate the recharging of the activesubstances 9 and 10 to the fabric 1 for domestic three grams ofsubstances 9 and 10 in microcapsules 11 are brought and they aredissolved into 300-500 ml. of water, after to have washed the usedfabric 1, at a temperature inferior to 40° C. The pantyhose, or the sockor the other forms of the fabric 1 are then left in soaking for 15-20minutes. These products are then dry in air. After this treatment thefabric 1 have an uniform distribution of the active principles. Withpre-determined times are provided rechargings, also conserving theactive principles effectiveness till the third days of use. The inventedproduct conserves the active principles also after three washings.However, it is suggested the daily washing and the recharging afterthree days from the first use with the method above described. Thesimple application of a cream with active principles does not reach theuseful results for the diabetic foot pathology such as the resultsobtained with the invention such as the friction of the foot with theconventional pantyhose creates, during the walk, frictions that take offthe cream instead of makes it to absorb to the skin of the foot andneither the occlusive bandages with cream and gauzes are not to be usedif no with the patient in bed. The invention is so to be used in thedaily without constraints and/or changing to the style of life of thepatient. The invention in the application in the form of applicationalso winding bandage 5, cicatrizant bandage or plaster 6 haveapplication also remedy for the bedsores and/or light wounds. Thecicatrizant action, the better of the micro-circulation and the effecton the derma determine a quick healing of these woods without collateraleffects. The invention is illustrated in a merely indicative way in thedrawings of sheets 1 and 2. In sheet 1 FIG. 1 is view of an example ofproduction like a stocking. In the same table 1 the FIG. 2 is view of anapplication like a stock. FIG. 3 is view of the version like apantyhose. FIG. 4 is view of the version of winding bandage with closedprofile. FIG. 5 is view of the version of bandage or plaster. In sheet 2are illustrated some sequences of the recharging phase of the activeprinciples of the invention. In detail FIG. 6 is view of the immersionphase. FIG. 7 is view of the invention soaks in water with the activeprinciples.

1. Fabric with active principles and relevant recharging method of the active principles characterized in that a fabric (1) consists of lycra fibres and micro-fibres and it has distributed long the fibres a glycoprotein (9) and an exapeptide (10) and that the woof of said fabric and the active principles given to these two substances prevent and/or give the first cures to the diabetic foot.
 2. Fabric with active principles and relevant recharging method according to claim 1, characterized in that the fabric (1) with the substances (9, 10) have the production form of a stocking (2), of a pantyhose (3), of a sock (4), of a winding bandage with closer border (5) of a bandage or plaster (6) so to realize a continuous and persistent contact with the skin of the diabetic patient.
 3. Fabric with active principles and relevant recharging method according to claim 1, characterized in that the fabric (1) has in the woof thin silver yarns (7) for a anti-bacteric and bacteriostac function.
 4. Fabric with active principles and relevant recharging method of the active principles according to claim 1, characterized in that the active principles (8, 9) are mixed into microcapsules (11) soluble in water.
 5. Fabric with active principles and relevant recharging method according to claim 1, characterized in that to have the concentration of glycoprotein (9) to the wet fabric (1) in quantity of at least 1 mg/ml.
 6. Fabric with active principles and relevant recharging method of the active principles according to claim 1, characterized in that to have the concentration of exapeptide (10) to the fabric in quantity at least of 0.05 mg/ml.
 7. Fabric with active principles and relevant recharging method of the active principles according to claim 1, characterized in that the recharging or the first charging of the washed fabric is actuated bathing with clean water the fabric (1) to which is added a fixer (12), the nylofixan PM, in proportion of 4% of the weight of the fabric (1) to be treated, with the subsequent putting in water of soluble capsules (11) containing the active principles (8, 9) in total quantity equal to 6% of the weight of the fabric and, at the end, after ten minutes, is added the softenol 70 in percentage of 2% of the weight of the fabric and after ninety minutes the bath is discharge and the fabric (1) is centrifuged and drying, prompt to be used.
 8. Fabric with active principles and relevant recharging method of the active principles according to claim 1, characterized in that to provide, for the recharging in domestic use, the use of three grams of the substances (9, 10) into the microcapsules (11) dissolve into 300-500 ml. of water at a temperature inferior to 40° C. and soaking of the fabric (1) for at least fifteen minutes.
 9. Fabric with active principles and relevant recharging method of the active principles according to claim 1, characterized in that it is used like a remedy for the bedsores or for the light wounds. 